Astellas Cresemba Clears FDA For Orphan, But Not Limited, Populations
Firm adds third antifungal to its portfolio.
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Sanofi’s Praluent Closes Gap On Repatha In Europe, As GSK Gets Green Light For World’s First Malaria Vaccine
Europe’s CHMP grants positive opinions for Sanofi’s Praluent and GSK’s not-for-profit malaria vaccine Mosquirix at July meeting; other products recommended include Shire’s Intuniv, Merck’s Zerbaxa, Basilea’s Cresemba and Keryx’s Fexeric.
Cresemba (isavuconazonium), the first antifungal approved with added exclusivity award for Qualified Infectious Disease Products, also becomes first product to receive both QIDP and Orphan Drug exclusivity.
Deal brings CHF75 million upfront plus welcome validation after Basilea's break-up with J&J on ceftobiprole.